The FDA says substantial improvement on an a relev
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Posted On: 01/22/2022 9:01:41 PM
Re: craigakess #115757
The FDA says substantial improvement on an a relevant endpoint needed for a BTD. Median progression free survival is a relevant endpoint and our improvement was substantial on top of superior safety. When you use vague terminology like substantial and relevant you have plausible deniability for your decisions.
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